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The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The shoulder coil is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the body. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The indications for use are as follows:

The MR-RSC-150 Shoulder coil is a receive-only multiple array coil used for MRI imaging of the human shoulder, its surrounding structures and other large joints.

The Echelon Shoulder Coil is a receive only RF phased array coil, used for obtaining diagnostic images of the abdominal region, in an open Magnetic Resonance Imaging (MRI) system.

The Shoulder coil is a receive-only coil designed to contour to the outline of the shoulder. The coil consists of 5 elements. The signal output of each element is independently processed by the MRI system to enhance performance.

The provided text is a 510(k) summary for the Echelon™ MR-RSC-150 Shoulder Coil. This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a specific study proving device performance against such criteria, or the details of a clinical study as requested.

The document states:

• "It is the opinion of Hitachi Medical Systems America that the Echelon™ Shoulder Coil is substantially equivalent to the Shoulder coil cleared in AIRIS II MRI System (Cf. K992650). The technological characteristics and intended use are identical to the Predicate Device."
• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the submission relies on demonstrating substantial equivalence to a previously cleared device, rather than providing new performance data from a clinical study with acceptance criteria.

Therefore, I cannot provide the requested information, which typically comes from clinical performance studies. The provided text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set, data provenance, or details about retrospective/prospective studies.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, or effect sizes for AI assistance.
6. Results from a standalone algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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